Cleared Traditional

ACTIFY? 3D Total Knee System, ACTIFY? Total Knee System

K240669 · Globus Medical, Inc. · Orthopedic

Jun 2024

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K240669 is an FDA 510(k) clearance for the ACTIFY? 3D Total Knee System, ACTIFY? Total Knee System, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on June 20, 2024, 101 days after receiving the submission on March 11, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K240669 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 2024
Decision Date	June 20, 2024
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560